2025-521762-99-00RecruitingPhase 3
Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants
Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Sept 2026
Brief summary (registry, in English)
To assess whether intravenous thrombolysis with tenecteplase 0.25 mg/kg improves functional outcome after acute ischemic stroke in patients taking direct oral anticoagulants compared to placebo.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 668 (estimated)
- First submitted
- 1 Oct 2025
- Start date
- 9 Mar 2026
- Lead sponsor
- University Medical Center Hamburg-Eppendorf
- Diseases
- Stroke
- EU CT number
- 2025-521762-99-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 668
- 42 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to intravenous thrombolysis, except DOAC therapy
- Concomitant therapy with antithrombotic medications, except DOACs
- Any anticipated surgical intervention within 12 hours
Other illness
- Significant pre-stroke disability (mRS > 3)
Other
- Reversal or planned reversal of anticoagulation with idarucizumab or andexanet alfa
- Anticipated stenting of cervical or intracranial artery within 12 hours
- Anticipated coronary angioplasty within 12 hours
Who the study is looking for
- Age ≥ 18 years
- Clinical diagnosis of acute stroke with disabling deficit
- National Institutes of Health Stroke Scale (NIHSS) score at least 2
- Recent intake (within 48 hours prior to enrolment) of a direct oral anticoagulant (apixaban, rivaroxaban, edoxaban, or dabigatran)
- No evidence of any intracranial haemorrhage on cerebral imaging (CT or MRI) performed after stroke onset and no earlier than 60 minutes before enrolment
- Stroke symptoms not known to have been present for > 6 h
- For patients not known to have been awake and without acute stroke symptoms within 4.5 hours prior to enrolment, additional imaging criteria must be satisfied: a) If stroke symptoms are known to have been present for > 4.5 h (late time window): core/penumbra mismatch on MR or CT perfusion imaging; b) If stroke symptoms are not known to have been present for > 4.5 h (unknown time window): core/penumbra mismatch on MR or CT perfusion imaging; or DWI/FLAIR mismatch on MR imaging.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Aachen AöR | Aachen | Germany | Recruiting |
| Klinikum Altenburger Land GmbH | Altenburg | Germany | Recruiting |
| Kamillus Klinik Asbach gGmbH | Asbach | Germany | Recruiting |
| Klinikum Aschaffenburg-Alzenau gGmbH | Aschaffenburg | Germany | Recruiting |
| Universitaetsklinikum Augsburg | Augsburg | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Recruiting |
| Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH | Bochum | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Recruiting |
| Gesundheit Nord gGmbH Klinikverbund Bremen | Bremen | Germany | Recruiting |
| Klinikum Chemnitz gGmbH | Chemnitz | Germany | Recruiting |
| Klinikum Dortmund gGmbH | Dortmund | Germany | Recruiting |
| Technische Universitaet Dresden | Dresden | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR | Duesseldorf | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR | Erlangen | Germany | Recruiting |
| Klinikum Frankfurt Hoechst GmbH | Frankfurt Am Main | Germany | Recruiting |
| Martha-Maria Krankenhaus Halle-Doelau gGmbH | Halle (saale) | Germany | Recruiting |
| Asklepios Kliniken Hamburg GmbH | Hamburg | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Germany | Recruiting |
| Katholische Hospitalvereinigung Weser-Egge gGmbH | Hoexter | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR | Kiel | Germany | Recruiting |
| Universitaet Leipzig | Leipzig | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR | Luebeck | Germany | Recruiting |
| Staedtisches Klinikum Lueneburg gGmbH | Lueneburg | Germany | Recruiting |
| Otto Von Guericke Universitaet Magdeburg | Magdeburg | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Recruiting |
| Heidelberg University | Mannheim | Germany | Recruiting |
| Philipps-Universitaet Marburg | Marburg | Germany | Recruiting |
| Evangelisches Krankenhaus Mettmann GmbH | Mettmann | Germany | Recruiting |
| Muehlenkreiskliniken AöR | Minden | Germany | Recruiting |
| Kliniken Maria Hilf GmbH Moenchengladbach | Moenchengladbach | Germany | Recruiting |
| Universitaet Muenster | Muenster | Germany | Recruiting |
| LMU Klinikum Muenchen AöR | Munich | Germany | Recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) | Munich | Germany | Recruiting |
| Klinikum Nuernberg | Nuremberg | Germany | Recruiting |
| Evangelische Krankenhausstiftung Oldenburg | Oldenburg | Germany | Recruiting |
| Klinikum Osnabrueck GmbH | Osnabrueck | Germany | Recruiting |
| Klinikum Ernst von Bergmann gGmbH | Potsdam | Germany | Recruiting |
| Universitaetsklinikum Regensburg AöR | Regensburg | Germany | Recruiting |
| Klinikum Der Landeshauptstadt Stuttgart gKAöR | Stuttgart | Germany | Recruiting |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH | Wiesbaden | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR | Wuerzburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.